CN114828915A

CN114828915A - Component positioning for linear reciprocating pump

Info

Publication number: CN114828915A
Application number: CN201980102808.1A
Authority: CN
Inventors: A·鲍泽; S·卡尔迪纳利
Original assignee: Insulet Corp
Current assignee: Insulet Corp
Priority date: 2019-11-05
Filing date: 2019-11-05
Publication date: 2022-07-29
Also published as: WO2021091537A1; AU2019473403A1; EP4054677A1; AU2019473403B2; CA3156331A1

Abstract

Wearable drug delivery devices and methods for component positioning of linear reciprocating pumps are disclosed herein. In some methods, the pump may include a pump chamber operably coupled with the piston and a stop device, wherein the stop device includes a stop body, a stop arm, and a stop engagement member. The stop engagement member may remain in direct physical contact with the stop body or the stop arm in either the first captured position or the second captured position. The pump may also include a piston grip coupled to the piston, the piston grip including a grip member that engages an exterior of the piston. Movement of the piston grip may cause the piston to move axially relative to the pump chamber to control the receipt and delivery of the liquid medicament.

Description

Component positioning for linear reciprocating pump

Technical Field

Embodiments herein relate generally to drug delivery. More particularly, embodiments herein relate to wearable drug delivery devices and methods for component positioning of linear reciprocating pumps.

Background

Many wearable drug delivery devices comprise a container for storing a liquid drug. A drive mechanism, such as a pump including a pump chamber and a piston, is operated to expel the stored liquid drug from the container for delivery to a user. One problem with the known device is that: when the volume of the drug is small, the accuracy of the delivery rate is affected. In many cases, this inaccuracy is caused by the drive mechanism or mechanisms employed, which cause variations in the delivery rate. Accordingly, there is a need to provide a wearable drug delivery device that is capable of adjusting drug delivery dose while verifying drive mechanism positioning and sequence.

Disclosure of Invention

In one method of the present disclosure, a pump may include a pump chamber operatively coupled with a piston and a stop device coupled to the pump chamber or the piston. The stop apparatus may include a stop body, a stop arm, and a stop engagement member, wherein in a first position, the stop engagement member remains in contact with a first captured position of the stop body or the stop arm, and wherein in a second position, the stop engagement member remains in contact with a second captured position of the stop body or the stop arm. The pump may further include a piston grip coupled to the piston, the piston grip including a grip member that engages an exterior of the piston, wherein movement of the piston grip causes the piston to move axially relative to the pump chamber to control the receipt and delivery of the liquid medicament.

In another method of the present disclosure, a linear displacement reciprocating pump may include a pump chamber operatively coupled with a piston and a stop device coupled to the pump chamber or the piston. The stop apparatus may include a stop body, a stop arm, and a stop engagement member, wherein the stop engagement member is operable to move between a first captured position and a second captured position disposed along the stop body or the stop arm. The linear volume reciprocating pump may further comprise a piston grip coupled to the piston, the piston grip comprising a grip member engaged with an exterior of the piston, wherein movement of the piston grip causes the piston to move axially relative to the pump chamber to control the receipt of the liquid medicament from the container and the delivery of the liquid medicament from the pump chamber.

In yet another method of the present disclosure, a linear volume reciprocating pump may include a pump chamber operatively coupled with a piston and a stop device coupled to the pump chamber or the piston. The stop apparatus may include a stop body, a stop arm, and a stop engagement member, wherein the stop engagement member is operable to move between a first captured position and a second captured position disposed along the stop body or the stop arm. The linear volume reciprocating pump may further comprise a piston grip coupled to the piston, the piston grip comprising a grip member engaged with an exterior of the piston, wherein movement of the piston grip causes the piston to move axially relative to the pump chamber to control the receipt of the liquid medicament from the container and the delivery of the liquid medicament from the pump chamber. The linear volume reciprocating pump may further comprise a contact portion extending from the stop device or the piston catch, the contact portion being operable to establish or break contact with one or more contact members coupled to the pump chamber.

Drawings

The accompanying drawings illustrate an exemplary method of the present disclosure, including a practical application of its principles, as follows:

FIG. 1 illustrates a perspective view of an exemplary linear volume reciprocating fluid pump, in accordance with embodiments of the present disclosure;

FIG. 2 illustrates a top view of the linear volume reciprocating fluid pump depicted in FIG. 1, in accordance with an embodiment of the present disclosure;

FIG. 3 illustrates a perspective view of an exemplary linear volume reciprocating fluid pump, in accordance with embodiments of the present disclosure;

FIG. 4 illustrates another view of the linear volume reciprocating fluid pump depicted in FIG. 3, in accordance with an embodiment of the present disclosure;

FIG. 5 illustrates a top view of an exemplary linear volume reciprocating fluid pump, in accordance with embodiments of the present disclosure;

FIG. 6 illustrates a perspective view of the linear volume reciprocating fluid pump depicted in FIG. 5, in accordance with an embodiment of the present disclosure;

FIG. 7 illustrates a perspective view of an exemplary linear volume reciprocating fluid pump, in accordance with embodiments of the present disclosure;

FIG. 8 illustrates a top view of the linear volume reciprocating fluid pump depicted in FIG. 7, in accordance with an embodiment of the present disclosure;

FIG. 9 illustrates a perspective view of an exemplary pump casing according to an embodiment of the present disclosure;

FIG. 10 illustrates a top view of an exemplary linear volume reciprocating fluid pump, according to an embodiment of the present disclosure;

11-12 illustrate close-up views of a stop device of the linear volume reciprocating fluid pump depicted in FIG. 10, in accordance with an embodiment of the present disclosure;

13-14 illustrate top views of exemplary linear volume reciprocating fluid pumps according to embodiments of the present disclosure;

15-16 illustrate perspective views of exemplary linear volume reciprocating fluid pumps according to embodiments of the present disclosure;

17-18 illustrate perspective views of exemplary linear volume reciprocating fluid pumps according to embodiments of the present disclosure;

19-20 illustrate perspective views of the contacts of the linear volume reciprocating fluid pump depicted in FIGS. 17-18, in accordance with an embodiment of the present disclosure;

21-22 illustrate perspective views of exemplary linear volume reciprocating fluid pumps according to embodiments of the present disclosure;

FIG. 23 illustrates a top view of the linear volume reciprocating fluid pump depicted in FIGS. 21-22, in accordance with an embodiment of the present disclosure;

FIG. 24 illustrates a sequence for operating an exemplary linear volume reciprocating fluid pump, in accordance with an embodiment of the present disclosure;

25-26 illustrate perspective views of an exemplary linear volume reciprocating fluid pump according to embodiments of the present disclosure;

FIG. 27 shows a top view of the linear volume reciprocating fluid pump depicted in FIGS. 25-26, in accordance with an embodiment of the present disclosure;

FIG. 28 illustrates a sequence for operating an exemplary linear volume reciprocating fluid pump according to an embodiment of the present disclosure;

29-30 illustrate perspective views of an example linear volume reciprocating fluid pump including an optical sensor, according to embodiments of the present disclosure;

FIG. 31 illustrates a perspective view of an exemplary linear volume reciprocating fluid pump including an optical sensor, in accordance with embodiments of the present disclosure;

FIG. 32 illustrates a cross-sectional view of the linear volume reciprocating fluid pump depicted in FIG. 31, in accordance with an embodiment of the present disclosure;

FIG. 33 illustrates a perspective view of the linear volume reciprocating fluid pump depicted in FIG. 31, in accordance with an embodiment of the present disclosure; and

34-35 illustrate perspective views of an exemplary linear volume reciprocating fluid pump including a capacitive sensor, according to embodiments of the present disclosure.

The drawings are not necessarily to scale. The drawings are merely illustrative and are not intended to depict specific parameters of the disclosure. The drawings are intended to depict example embodiments of the disclosure, and therefore should not be considered as limiting in scope. In the drawings, like numbering represents like elements.

Also, for clarity of illustration, certain elements in some of the figures may be omitted or not shown to scale. The cross-sectional view may be in the form of a "slice" or "near-sighted" cross-sectional view, with certain background lines that would otherwise be visible in the "true" cross-sectional view omitted for clarity of illustration. Also, some reference numerals may be omitted in some drawings.

Detailed Description

Various methods according to the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the methods are shown. These methods may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the methods to those skilled in the art.

Various examples disclosed herein provide drive mechanisms and/or pump systems with the ability to control and verify pump sequences. As a result, the drug delivery device comprising the reservoir and the pump may be made more reliable and thus safer for the user.

The various examples described herein enable a pump, such as a linear displacement reciprocating pump (LVSP), to perform pumping cycles in the proper sequence. At any given time during pump actuation, it is beneficial to know the positions of the different pump components (i.e., the pump chamber and the piston) because the pump chamber and the piston are responsible for drawing in and expelling fluid. Knowing the position of both the pump chamber and the piston also indicates whether the pump is operating in the designed sequence. In some examples of the disclosure, one or more mechanical stop and sensing/sequencing mechanisms may be implemented with the pump to both control the position of the pump chamber and piston to maintain the pump cycle in proper sequence, and to provide feedback on the position of the pump chamber and/or piston. As will be described in greater detail herein, various methods and devices may be implemented for tracking the position of the pumping chamber and piston, such as electromechanical contacts, optical sensing, and/or capacitive sensing.

Fig. 1-2 illustrate a linear volume reciprocating fluid pump 100 (hereinafter "pump") according to an embodiment of the present disclosure. As shown, the pump 100 may include a pump housing 102 that connects together a fluid reservoir 104, a pump chamber 106, and a piston 108. In some embodiments, the fluid container 104 may contain a fluid or liquid medicament. The pump casing 102 may include: a base 110; a base frame 111 extending from the base 110 for holding the pump chamber 106; and a container wall 112 operable to interface with the pump chamber 106, as will be described in greater detail herein. Although not limiting, the pump housing 102 may be formed from injection molded plastic or other similar material.

Although not shown, the pump chamber 106 may include an inlet passage or member and an outlet passage or member. The liquid or fluid may enter the pump chamber 106 through an inlet passageway and may exit the pump chamber 106 through an outlet passageway. One or more plunger members are operable with the inlet and outlet passageways to draw fluid into the pump chamber 106 and expel fluid from the pump chamber 106. In various examples, the pump chamber 106 can be coupled to a fluid container 104 that stores a fluid or liquid medicament. For example, the inlet passageway may be coupled to the fluid container 104 and the outlet passageway may be coupled to a fluid path component (not shown) that is coupled to a patient or user that is to receive the liquid medicament stored in the fluid container 104.

As further shown, the pump 100 can include a stop device 115 coupled to the pump chamber 106. In some embodiments, the stopping device 115 may include: a stopper cover or stopper body 116; one or more stop arms 117 extending from the stop body 116; and one or more stop engaging members 118. The stop body 116 may extend over and/or abut one end of the pump chamber 106. In some embodiments, the stop body 116 may also abut the piston 108, wherein an opening (not shown) of the stop body 116 may allow a rod of the piston 108 to pass therethrough.

The stopping arm 117 may include a first capture position 120 and a second capture position 121. As shown, the first capture position 120 and the second capture position 121 may correspond to a valley or valley disposed between one or more peaks 122. The first and second capture positions 120, 121 may be curved to generally complement the size of the stop engaging member 118, in this case the stop engaging member 118 is a coil spring extending from the base 110 of the pump housing 102. The first and second capture positions 120, 121 allow discrete positioning of the pump chamber 106 and/or piston 108 by adding additional friction to limit movement of the stop body 116 before the desired time.

In the non-limiting embodiment shown, the stop engagement member 118 contacts the first capture position 120 of the stop arm 117 when in the first position. In the second position, the stop engagement member 118 may be in contact with the second capture position 121 of the stop arm 117. The stop engagement member 118 may be changed between the first position and the second position as the pump chamber 106 is moved relative to the fluid container 104.

As further shown, the pump 100 can include a piston grip 125 coupled to the piston 108. The piston grip 125 may include one or more grip members 126 that engage the exterior of the piston 108. During operation, movement of the piston catch 125 causes the piston 108 to move axially relative to the pump chamber 106 to control the receipt and delivery of liquid medicament within the pump chamber 106. The piston grip 125 can be actuated by a variety of mechanisms and/or actuators. In various examples, the piston grip 125 can be actuated by an actuator capable of producing a reciprocating motion, such as a piezoelectric-based actuator, a solenoid-based actuator, a nitinol-based actuator, a spring-based actuator, a rotating electric machine with a geared drive train, a Direct Current (DC) motor, or any combination thereof. As a result, the desired effect of the reciprocating fluid (e.g., liquid medication) may be achieved.

In some embodiments, the piston grip 125 includes grip bodies 127 extending on opposite sides of the piston 108. The gripper body 127 may be a generally planar member that includes one or more spring feet 128 extending therefrom. As shown, each spring foot 128 may include one or more tabs 171 to engage and retain the side springs 129 therein. In this embodiment, side springs 129 may be disposed on opposite sides of the piston 108, parallel to a central axis (not shown) extending through the piston 108, the pump chamber 106, and the stop body 116. The side spring 129 may provide a spring force to bias the piston catch 125, and thus the piston 108, toward the pump chamber 106.

As shown in fig. 3-4, in some embodiments, the pump 100 may include a stop cap 130 positioned on top of the stop engaging member 118 to provide support/rigidity to the stop engaging member, as the stop engaging member 118 may be susceptible to unpredictable bi-stable behavior. In some embodiments, the stop cap 130 can include an elongated body 131 extending between the free ends of each of the stop engaging members 118. As shown, a vertical shaft 132, which may extend from the underside of the elongated body 131, extends into a central cavity defined by the helical structure of each of the stop engaging members 118.

Turning now to fig. 5-6, a pump 200 according to an embodiment of the present disclosure will be described in more detail. The pump 200 may be similar in many respects to the pump 100 described above. Thus, for the sake of brevity, only certain aspects of the pump 200 may be described below. In this embodiment, pump 200 may include a stop device 215 coupled to a piston rod 234 of piston 208. The detent device 215 may include a detent body 216, which may be coupled to the housing 202 or integrally formed with the housing 202. Stop device 215 may also include one or more stop arms 217 extending from piston rod 234, wherein each stop arm 217 includes one or more stop engaging members 218 that engage stop body 216. In some embodiments, the stop arm 217 may be a rigid or semi-rigid element that extends toward the container wall 212 of the fluid container 204. Each of stop arms 217 may be allowed to flex radially to some extent relative to pump chamber 206 as pump chamber 206 moves axially relative to fluid container 204.

The stop body 216 may include a first capture position 220 and a second capture position 221. As shown, the first and second capture positions 220, 221 can correspond to recesses or valleys 216 disposed along the sidewall 233 of the stop body 216 between the protrusions or peaks 222. In some embodiments, the first and second capture positions 220, 221 may be curved or slotted to generally complement the size of the stop engaging member 218. The first and second capture positions 220, 221 allow for discrete positioning of the pump chamber 206 and/or piston 208 during use. For example, each stop engagement member 218 may move from a first capture position 220 to a second capture position 221 as the piston 208 moves relative to the fluid container 204.

Turning now to fig. 7-8, a pump 300 according to an embodiment of the present disclosure will be described in more detail. Pump 300 may be similar in many respects to

pumps

100 and 200 described above. Thus, for the sake of brevity, only certain aspects of the pump 300 are described below. In this embodiment, the pump 300 may include a stop device 315 coupled to the pump chamber 306. The stop apparatus 315 may include a stop body 316 that may be coupled to the pump casing 302 or integrally formed with the pump casing 302. For example, the stop body 316 may correspond to an outer surface 337 of the chassis 311 extending from the base 310 of the pump casing 302.

The stop device 315 can also include one or more stop arms 317 extending from the outer surface 345 of the pump chamber 306. As shown, the stop arm 317 may extend generally radially away from the pump chamber 306. Each stop arm 317 may include an opening 335 that receives a stop engagement member 318 therein. In this embodiment, the stop engaging member 318 may be a coil spring extending from the base 310 of the pump housing 302. As shown, the stop engagement members 318 may be joined together by a connector 338 to provide rigidity and support thereto. In addition, a connector 338 may provide an electrical connection between each of the stop engaging members 318.

The stopper body 316 may include a first capture position 320 and a second capture position 321. As shown, the first and second capture positions 320, 321 may correspond to recesses or valleys disposed along the outer surface 337 of the stop body 316 between the protrusions or peaks 322. In some embodiments, the first and second capture positions 320, 321 may be curved or slotted to generally complement the size of the stop engaging member 318. The first and second capture positions 320, 321 allow for discrete positioning of the pump chamber 306 and/or piston 308 during use.

In this embodiment, the stop body 316 may include one or more contact signal pins 344 embedded therein. As shown, the contact signal pins 344 may be positioned within the second capture locations 321. In other embodiments, the contact signal pins 344 may be positioned within the first capture location 320, or within both the first capture location 320 and the second capture location 321. With the contact signal pins 344 positioned in both the first capture position 320 and the second capture position 321, two different on/off states may be recorded instead of a single "on" or "off" state. This may be accomplished, for example, using a live contact signal pin 344 in each of the first and

second capture locations

320, 321 on one side of the pump chamber 306 and a different contact signal pin in the corresponding capture location on the opposite side of the pump chamber 306.

During use of the pump 300, the contact signal pin 344 may not be in contact with the stop engaging member 318 when the pump chamber 306 is in the first position. When the pump chamber 306 is moved away from the container wall 312 of the fluid container 304 to a second position within the second captured position 321, the contact signal pin 344 is in contact with the stop engagement member 318. Thus, a closed loop is formed between the contact signal pin 344 and the stop engagement member 318, thereby allowing the signal to be transmitted to a processor or control logic/loop (not shown). For example, the signal obtained by actuating the closed circuit switch may be an indicator of the status or position of the pump chamber 306. The information obtained by the closed-circuit switch regarding the position of the pump chamber 306 can be used, for example, to ensure that the pump 300 is properly drawing or expelling fluid.

Turning now to fig. 9, the pump housing 302 of the pump 300 according to an embodiment of the present disclosure will be described in more detail. As shown, the pump housing 302 may include a base 310 and a chassis 311 extending from the base 310 for holding the pump chamber 306 (fig. 7-8). The pump housing 302 may also include a reservoir housing 350 defining or housing the fluid reservoir 304, wherein the fluid reservoir contains a fluid medicament therein. The vessel wall 312 may extend along the exterior of the vessel shell 350, the vessel wall 312 including a fluid opening 351 formed therethrough. In some embodiments, a needle (not shown) may extend through the fluid opening 351 to draw fluid medication into the pump chamber 306.

In other embodiments, the piston rod of the piston 308 may extend into the fluid opening 351, initially preventing the fluid medicament from being released from the fluid container 304. When the piston rod is withdrawn from the reservoir housing 350, e.g., axially away from the reservoir wall 312, the fluid medicament may be released from the fluid reservoir 304 and into the pump chamber 306. In some embodiments, movement of the piston rod may create a vacuum within a portion of the pump chamber 306 (such as within the fluid line). The vacuum may pull a portion of the fluid medicament out of the fluid container 304 and into the formed space/volume within the pump chamber 306.

As further shown, the chassis 311 may include a first (proximal) end 353 and a second (distal) end 354. A channel 355 may be provided in the base frame 311 to support the pump chamber 306. During use, pump chamber 306 may slide within channel 355 between first end 353 and second end 354. The base 310 of the pump housing 302 may also include one or more openings 356 for receiving one or more contact members (not shown).

Referring to fig. 10-12, a pump 400 according to an embodiment of the present disclosure will be described in more detail. The pump 400 may be similar in many respects to the pumps described above. Thus, for the sake of brevity, only certain aspects of the pump 400 may be described below. In this embodiment, the pump 400 may include a stop device 415 coupled to the pump chamber 406. In some embodiments, retaining device 415 may include: a stopper cover or stopper body 416; one or more stop arms 417 extending from the stop body 416; and one or more stop engagement members 418. The stop body 416 may extend over and/or abut one end of the pump chamber 406. In some embodiments, the stop body 416 may also abut the piston 408, wherein an opening (not shown) of the stop body 416 may allow a rod of the piston 408 to pass therethrough.

Stop arm 417 may include a first capture position 420 and a second capture position 421. As shown, the first capture position 420 and the second capture position 421 may be defined by valleys or valleys disposed between one or more peaks 422. The first and second capture positions 420 and 421 may be curved to generally complement the size of the stop engaging member 418, in which case the stop engaging member 418 is a torsion spring extending from the base 410 of the pump housing 402. More specifically, the stop engagement member 418 may include a contact portion 458, the contact portion 458 being connected to a helical portion 459. In some embodiments, the coil portion 459 may be received or embedded within a spring housing 460 (fig. 12), which spring housing 460 may extend from the base 410 or be integrally formed with the base 410. The first capture position 420 and the second capture position 421 allow for discrete positioning of the pump chamber 406 and/or the piston 408 by adding additional friction to limit movement of the stop device 415 before a desired time.

In the non-limiting embodiment shown, when in the first position, the contact portion 458 of the stop engagement member 418 may remain in physical and/or electrical contact with the first captured position 420 of the stop arm 417. In the second position, contact portion 458 of stop engagement member 418 may remain in physical and/or electrical contact with second captured position 421 of stop arm 417. As the pump chamber 406 moves away from the container wall 412, the stop engagement member 418 can change between a first position and a second position.

Referring to fig. 13-14, a pump 500 according to an embodiment of the present disclosure will be described in more detail. The pump 500 may be similar in many respects to the pumps described above. Thus, for the sake of brevity, only certain aspects of the pump 500 are described below. In this embodiment, pump 500 can include a stop device 515 coupled to pump chamber 506. In some embodiments, the stopping device 515 may include: a retaining cap or body 516; one or more stop arms 517 extending from the stop body 516; and one or more stop engagement members 518. Stop body 516 may extend over and/or abut one end of pump chamber 506. In some embodiments, the stop body 516 may also abut the piston 508, wherein an opening (not shown) of the stop body 516 may allow a rod 534 (fig. 14) of the piston 508 to pass therethrough.

The stop arm 517 may include a first capture position 520 and a second capture position 521. As shown, the first and second capture positions 520, 521 may be defined by valleys or valleys disposed between one or more peaks 522. The first and second capture positions 520, 521 may be curved to generally complement the size of the stop engagement member 518, in which case the stop engagement member 518 may be a coil spring extending from the base 510 of the pump housing 502. First capture position 520 and second capture position 521 allow discrete positioning of pump chamber 506 and/or piston 508 by adding additional friction to limit movement of stop device 515 before a desired time.

In this embodiment, one or more of the stop engagement members 518 may include an insulating coating 562 formed thereon. As shown, the insulating coating 562 can be formed along only a portion of the stop arm such that the first capture position 520 remains uncovered by the insulating coating 562. During use, as the pump chamber 506 and the stop device 515 are moved away from the fluid container 504, the stop arm 517 is repositioned relative to the stop engaging member 518 from the first captured position 520 to the second captured position 521, thus terminating electrical contact between the stop engaging member 518 and the stop arm 517 due to the presence of the insulating coating 562. In other embodiments, the first capture locations 520 may be covered by the insulating coating 562, while the second capture locations 521 are not covered by the insulating coating 562. Thus, movement of the stop engaging member 518 from the first captured position 520 to the second captured position 521 may cause a closed loop to be formed between the stop engaging member 518 and the stop arm 517. A signal indicative of the closed/open circuit connection between the stop engaging member 518 and the stop arm 517 can be used to determine the position of the pump chamber 506 and/or the piston 508.

Referring to fig. 15-16, a pump 600 according to an embodiment of the present disclosure will be described in more detail. The pump 600 may be similar in many respects to the pumps described above. Thus, for the sake of brevity, only certain aspects of the pump 600 are described below.

As shown, pump 600 may include one or more contact members 664, such as coil springs, extending from base 610 of pump housing 602. The contact member 664 may form a closed loop when the contact member 664 contacts the perimeter of the stop body 616 of the stop apparatus 615. For example, when the pump chamber 606 is in a first position adjacent the reservoir housing 650, as shown in figure 15, an open circuit exists. As the pump chamber 606 and the stop device 615 move toward the distal end 654 of the chassis 611, the perimeter 665 of the stop body 616 makes electrical and mechanical contact with the one or more contact members 664 to form a closed loop 670, as shown by the series of connecting arrows in fig. 16. A signal representative of the closed/open loop connection between the stop body 616 and the one or more contact members 664 can be used to determine the position of the pump chamber 606 and/or the piston 608.

In fig. 17-20, a pump 700 according to an embodiment of the present disclosure will be described in more detail. The pump 700 may be similar in many respects to the pumps described above. Thus, for the sake of brevity, only certain aspects of the pump 700 are described below.

As shown, the pump 700 may include one or more contact members 764, such as coil springs, extending from the base 710 of the pump housing 702. The contact member 764 may form a closed loop when the contact member 764 is in contact with the contact member 767 of the stop body 716 of the stop device 715. In this embodiment, the contact 767 may be an L-shaped contact extending from the stop body 716. As best shown in fig. 19-20, the contact 767 may include a set of crimps 768 operable to electrically and mechanically engage the contact member 764. For example, a contact member 767 can extend between each of the contact members 764, thereby deflecting the contact members 764 outward from a central axis (not shown) extending through the opening 769 (fig. 19) of the stop body 716. It should be understood that the particular geometry and configuration of the contact 767 is non-limiting.

In use, when the pump chamber 706 is in the first position adjacent the reservoir housing 750, as shown in figure 17, an open circuit exists. As the pump chamber 706 and the stop device 715 move toward the distal end 754 of the chassis 711, the contact member 767 makes electrical and mechanical contact with the contact member 764 to form the closed loop 770, as shown by the series of connecting arrows in figure 18. A signal representative of the closed/open loop connection between the contact member 767 and the contact member 764 can be used to determine the position of the pump chamber 706 and/or the piston 708.

Referring to fig. 21-23, a pump 800 according to an embodiment of the present disclosure will be described in more detail. The pump 800 may be similar in many respects to the pumps described above. Accordingly, for the sake of brevity, only certain aspects of the pump 800 are described below. In this embodiment, the pump 800 may include a piston grip 825 coupled with the piston 808. The piston grip 825 may include one or more grip members 826 that engage the exterior of the piston 808. During operation, movement of the piston grip 825 causes the piston 808 to move axially relative to the pump chamber 806 to control the receipt and delivery of liquid medicament within the pump chamber 806.

In some embodiments, the piston grip 825 includes a grip body 827 that extends on opposite sides of the piston 808. The grip body 827 may include one or more spring feet 828 extending therefrom. As shown, each spring foot 828 may include one or more tabs 871 to engage and retain the side springs 830 therein. In this embodiment, the side springs 830 may be disposed on opposite sides of the plunger 808, parallel to a central axis (not shown) extending through the plunger 808, the pump chamber 806, and the stopper body 816. The side spring 830 provides a spring force to bias the plunger catch 825, and thus the plunger 808, toward the pump chamber 806.

In this embodiment, the piston grip 825 can further include a contact member 867 coupled thereto. Although not limiting, the contact member 867 may be an insulated engagement pin disposed along the underside of the gripper body 827. For example, the contact 867 may be a conductive cylinder extending generally parallel to the central axis. In some embodiments, the contact member 867 can include a first end 872 retained within the clamp 873 of the piston grip 825 and a second free end 874 opposite the first end 872. The free end 874 is operable to engage one or more piston position contact members 875, as described below.

Referring now to fig. 24, the operation of the pump 800 according to an embodiment of the present disclosure will be described in more detail. As shown, for each state of the pump 800, a side view of the pump 800 and a close-up top view of the contact member 867 and the piston position contact member 875 are shown. In the initial stage (1), the pump chamber 806 may be directly adjacent to and/or abut the container wall 812 of the container housing 850. Additionally, when the pump chamber 806 is in the initial stage (1), the stop engagement member 818 may remain in direct physical contact with the first captured position of the stop arm 817. As shown, for example, there is no contact between the stop body 816 and the contact member 864, or between the contact 867 and the plunger position contact member 875.

Next, in a second stage (2), the piston 808 may be moved axially away from the pump chamber 806 to draw the liquid drug into the pump chamber 806. More specifically, the piston rod 834 of the piston 808 may be drawn axially through the pump chamber 806 to release the fluid medicament from the reservoir housing 850. As shown, the piston grip 825 and the contact member 867 can also move axially away from the pump chamber 806, causing the contact member 867 to engage the first pair 875A of the piston position contact members 875. A signal may be transmitted from the piston position contact member 875 to indicate the position of the contact 867, and thus the piston 808. An open circuit between the stop body 816 and the contact member 864 may provide an indication of the position of the pump chamber 806.

Next, in a third stage (3), the pump chamber 806 and the piston 808 may be moved axially away from the reservoir housing 850 to bring a needle (not shown) of the pump chamber 806 into a fluid output position. As shown, the piston grip 825 and the contact 867 can engage the first pair 875A and the second pair 875B of the piston position contact members 875. A signal may be transmitted from the piston position contact member 875 to indicate the position of the contact 867, and thus the position of the piston 808. Furthermore, the closed loop between the stop body 816 and the contact member 864 may also provide an indication of the position of the pump chamber 806. As shown, stop engagement member 818 may remain in direct physical contact with second capture location 821 of stop arm 817.

Next, in a fourth stage (4), the piston 808 may be moved axially toward the pump chamber 806 to expel fluid drug from the pump chamber 806. As shown, the piston grip 825 and the contact 867 can only engage a first pair 875A of the piston position contact members 875. A signal may be transmitted from the piston position contact member 875 to indicate the position of the contact 867, and thus the piston 808. Furthermore, the closed loop between the stop body 816 and the contact member 864 may also provide an indication of the position of the pump chamber 806. As shown, the stop engagement member 818 may remain in direct physical contact with the second captured position 821 of the stop arm 817 during the fourth stage.

Referring now to fig. 25-27, a pump 900 according to an embodiment of the present disclosure will be described in more detail. The pump 900 may be similar in many respects to the pumps described above. Thus, for the sake of brevity, only certain aspects of the pump 900 may be described below. In this embodiment, the pump 900 can include a piston grip 925 coupled with the piston 908. The piston grip 925 may include one or more grip members 926 that engage the exterior of the piston 908. During operation, movement of the piston grip 925 causes the piston 908 to move axially relative to the pump chamber 906 and the reservoir housing 950 containing the fluid medicament.

In some embodiments, piston grip 925 comprises a grip body 927 extending on opposite sides of piston 908 and a contact 967 coupled to the grip body. Although not limiting, the contact member 967 may be an engagement pin disposed along the underside of the gripper body 927. For example, the contacts 967 may be conductive cylinders that extend generally parallel to the central axis. Contacts 967 may include a first end 972 proximate to contact member 964 and a second end 974 proximate to one or more plunger position contact members 975. As shown, the contact 967 may be coupled to the grip body 927 by one or more clamps 973.

Turning now to fig. 28, the operation of the pump 900 according to embodiments of the present disclosure will be described in more detail. As shown, a side view of pump 900 is depicted along with a close-up top view of contacts 967, contact members 964, and piston position contact members 975 for each state of pump 900. In the initial stage (1), the pump chamber 906 may be directly adjacent to and/or abut the container wall 912 of the container housing 950. Additionally, the stop engagement member 918 may remain in direct physical contact with the first captured position 920 of the stop arm 917 when the pump chamber 906 is in the initial stage (1). As shown, contacts 967 may be in direct physical and electrical contact with contact members 964, but not with piston position contact members 975.

Next, in a second stage (2), the piston 908 may be moved axially away from the pump chamber 906 to draw the liquid drug into the pump chamber 906. More specifically, the piston rod 934 of the piston 908 may be drawn axially through the pump chamber 90 to release the fluid medicament from the reservoir housing 950. As shown, piston grip 925 and contact member 967 may also move axially away from pump chamber 906, causing contact member 967 to engage piston position contact member 975. Signals can be transmitted from piston position contact member 975 and contact member 964 to indicate the position of contacts 967, and thus piston 908.

Next, in a third stage (3), the pump chamber 906 and the piston 908 may be moved axially away from the reservoir housing 950 to bring a needle (not shown) of the pump chamber 906 into a fluid output position. As shown, the piston grip 925 and the contact member 967 can continue to move axially away from the container housing 950, causing the first end 972 of the contact member 967 to break contact with the contact member 964. One or more signals may be transmitted from piston positioning contact members 975 and contact members 964 to indicate the position of contacts 967, and thus piston 908. In some embodiments, the closed circuit between the stop body 916 and the contact member may also provide an indication of the position of the pump chamber 906. As shown, the stop engagement member 918 can remain in direct physical contact with the second capture position 921 of the stop arm 917.

Next, in a fourth stage (4), the piston 908 may be moved axially toward the pump chamber 906 to expel fluid drug from the pump chamber 906. As shown, contact 967 may again engage piston position contact 975 and contact member 964. Signals can be transmitted from piston position contact member 975 and contact member 964 to indicate the position of contacts 967, and thus piston 908. Moreover, the closed loop between the stop body 916 and the contact member 964 may also provide an indication of the position of the pump chamber 906. As shown, the stop engagement member 918 can remain in direct physical contact with the second capture position 921 of the stop arm 917 during the fourth stage.

Turning now to fig. 29-30, a pump 1000 in accordance with an embodiment of the present disclosure will be described in more detail. The pump 1000 may be similar in many respects to the pumps described above. Accordingly, for the sake of brevity, only certain aspects of the pump 1000 are described below. In this embodiment, pump 1000 can include a piston catch 1025 coupled with piston 1008. Piston catch 1025 may include one or more catch members 1026 that engage the exterior of piston 1008. During operation, the piston catch 1025 and the piston 1008 can move together axially relative to the pump chamber 1006.

In some embodiments, piston grip 1025 comprises grip bodies 1027 extending on opposite sides of piston 1008. The grip body 1027 can also include a sensor plate 1080 extending between a pair of side springs 1030. Sensor arm 1082 may extend perpendicularly from sensor plate 1080, wherein sensor arm 1082 operates in conjunction with optical sensor 1085 to detect the position of piston catch 1025, and thus, the position of piston 1008. More specifically, as better shown in fig. 30, the sensor arm 1082 can travel between a light source 1083 (e.g., an LED) and a photodiode 1084. The light source 1083 and the photodiode 1084 may extend from the base 1010 of the housing 1002.

The photodiode 1084 is operable to detect light from the light source 1083. When the sensor arm 1082 is positioned between the light source 1083 and the photodiode 1084, the photodiode will not detect any light. When the sensor arm 1082 is not positioned between the light source 1083 and the photodiode 1084, the photodiode detects light output from the light source 1083. Based on the detection or non-detection of light, the position of the piston catch 1025, and thus the position of the piston 1008, may be determined.

Turning now to fig. 31-33, a pump 1100 according to an embodiment of the present disclosure will be described in more detail. The pump 1100 may be similar in many respects to the pumps described above. Thus, for the sake of brevity, only certain aspects of the pump 1100 may be described below. In this embodiment, the pump 1100 may include a piston grip 1125 coupled to the piston 1108. During operation, movement of the piston catch 1125 causes the piston 1108 to move axially relative to the pump chamber 1106 and/or the piston rod 1134.

In some embodiments, the piston grip 1125 includes a grip body 1127 extending on opposite sides of the piston 1108. The grip body 1127 can also include a sensor plate 1180 extending between the pair of side springs 1130. As further shown, sensor plate 1180 may be positioned distal to plunger 1108. In this embodiment, the sensor board 1180 may include an optical opening 1186 positioned above the optical sensor 1185. Light from a light source (not shown) may reach photodiode 1184 of optical sensor 1185 depending on the position of sensor board 1180. For example, when the solid portion 1187 of the sensor arm 1182 is positioned between the light source and the photodiode 1184, the photodiode will not detect any light. However, when optical opening 1186 is positioned above photodiode 1184, light from a light source is allowed to reach photodiode 1184. Based on the detection or non-detection of light by photodiode 1184, the position of plunger catch 1125, and thus plunger 1108, may be determined. In some embodiments, the optical sensor 1185 may be raised to a position proximate the grip body 1127 by a sensor block 1190 extending from the base 1110 of the housing 1102 of the pump 1100. However, the embodiments herein are not limited in this context.

Turning now to fig. 34-35, a pump 1200 in accordance with an embodiment of the present disclosure will be described in more detail. The pump 1200 may be similar in many respects to the pumps described above. Thus, for the sake of brevity, only certain aspects of the pump 1200 are described below. In this embodiment, the pump 1200 may include a piston grip 1225 coupled to the piston 1208. During operation, movement of the piston grip 1225 causes the piston 1208 to move axially relative to the pump chamber 1206.

In some embodiments, the piston grip 1225 includes grip bodies 1227 extending on opposite sides of the piston 1208. The grip body 1227 can be operable with a capacitive sensor 1285. For example, the capacitive sensor 1285 can include a capacitive plate 1294 mounted on top of a capacitor block 1295, the capacitor block 1295 extending from the base 1210 of the housing 1202. During use, a temporary capacitor can be formed as the grounded gripper body 1227 is moved over the capacitor plate 1294. For example, capacitance may be measured by a component on a logic board (not shown) and may directly indicate the position of the piston grip 1215 and thus the position of the piston 1208. This approach can provide multiple resolutions between pump states because the capacitance measured with capacitive sensor 1285 increases and decreases linearly with movement of the gripper body 1227 of capacitive plate 1294.

In summary, the systems, devices, and methods disclosed herein may be used to extract a portion of a liquid drug or other fluid from a container. The pumps disclosed herein may be linear reciprocating pumps and/or linear volume reciprocating fluid pumps for providing stored liquid medication to a user by, for example, drawing liquid medication from a container, temporarily storing the drawn liquid medication within the pump, and then expelling the liquid medication from the pump for delivery to a patient. Each disclosed pump may be part of a wearable medical device, such as, for example, a wearable insulin delivery device.

The foregoing discussion is presented for purposes of illustration and description and is not intended to limit the present disclosure to the form or forms disclosed herein. For example, various features of the disclosure may be combined together in one or more aspects, embodiments, or configurations in order to simplify the disclosure. However, it should be understood that various features of certain aspects, embodiments or configurations of the present disclosure may be combined in alternative aspects, embodiments or configurations.

As used herein, an element or step recited in the singular and proceeded with the word "a" or "an" should be understood as not excluding plural elements or steps, unless such exclusion is explicitly recited. Furthermore, references to "one embodiment" of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features.

The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Thus, the terms "comprising," "including," or "having," and variations thereof, are open-ended and may be used interchangeably herein.

As used herein, the phrases "at least one," "one or more," and/or "are open-ended expressions that are both operationally associated and operationally separated. For example, "at least one of A, B and C," "at least one of A, B or C," "one or more of A, B and C," "one or more of A, B or C," and "A, B and/or C" refer to a alone, B alone, C, A and B together alone, a and C together, B and C together, or A, B and C together.

All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not constitute limitations, particularly as to the position, orientation, or use of the disclosure. Unless otherwise specified, connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements. Thus, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other.

Moreover, identifying references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but rather are used to distinguish one feature from another. The drawings are for illustrative purposes only and the dimensions, locations, order and relative dimensions reflected in the drawings may vary.

Moreover, the terms "substantially" or "substantially" and the terms "approximately" or "approximately" may be used interchangeably in some embodiments and may be described using any relative measure acceptable to one of ordinary skill in the art. For example, these terms can be used as a comparison with reference parameters to indicate a deviation from a desired function. Although not limiting, the deviation from the reference parameter can be, for example, an amount of less than 1%, less than 3%, less than 5%, less than 10%, less than 15%, less than 20%, and so forth.

Further, while various methods disclosed herein are described as a series of acts or events, the present disclosure is not limited by the illustrated ordering of such acts or events, unless otherwise specified. For example, some acts may occur in different orders and/or concurrently with other acts or events apart from those illustrated and/or described herein, in accordance with the disclosure. In addition, not all illustrated acts or events may be required to implement a methodology in accordance with the present disclosure. Moreover, the methods may be practiced in conjunction with the formation and/or treatment of structures illustrated and described herein, as well as in conjunction with other structures not illustrated.

The scope of the present disclosure is not limited by the specific embodiments described herein. Indeed, other various embodiments and modifications of the disclosure in addition to those described herein will be apparent to those of ordinary skill in the art from the foregoing description and accompanying drawings. Accordingly, such other embodiments and modifications are intended to fall within the scope of the present disclosure. Moreover, the present disclosure has been described herein in the context of a particular implementation in a particular environment for a particular purpose. Those of ordinary skill in the art will recognize that usefulness is not limited thereto and that the present disclosure may be beneficially implemented in any number of environments for any number of purposes. Accordingly, the claims set forth below should be construed in view of the full breadth and spirit of the present disclosure as described herein.

Claims

1. A pump, the pump comprising:

a pump chamber operatively coupled with a piston;

a stop device coupled to the pump chamber or the piston, wherein the stop device comprises a stop body, a stop arm, and a stop engagement member, wherein in a first position the stop engagement member remains in contact with a first captured position of the stop body or stop arm, wherein in a second position the stop engagement member remains in contact with a second captured position of the stop body or stop arm; and

a piston grip coupled to the piston, the piston grip comprising a grip member that engages an exterior of the piston, wherein movement of the piston grip causes the piston to move axially relative to the pump chamber to control the receipt and delivery of liquid medicament.

2. The pump of claim 1, further comprising a set of side springs coupled to the piston catch, wherein the set of side springs provide a spring force to bias the piston catch toward the pump chamber.

3. The pump of claim 1, further comprising a second stop engagement member, wherein a stop cap is positioned on top of the stop engagement member and the second stop engagement member.

4. The pump of claim 1, wherein the stop engaging member is a spring.

5. The pump of claim 1, wherein the stop body extends from a pump housing, wherein the stop arm is directly coupled to an outer surface of the pump chamber, and wherein the stop engagement member extends through an opening of the stop arm.

6. The pump of claim 5, further comprising a contact signal pin embedded within the stopper body, wherein in the first position the stopper engagement member is in contact with the contact signal pin, and wherein in the second position the stopper engagement member is not in contact with the contact signal pin.

7. The pump of claim 1, further comprising an insulating coating extending along a portion of the stop arm, wherein in the second position, the stop engagement member is in direct physical contact with the insulating coating.

8. The pump of claim 1, further comprising a contact extending from the stopper body or the piston grip, wherein the contact is operable to establish or break contact with one or more contact members.

9. The pump of claim 1, further comprising an optical or capacitive sensor positioned adjacent to the piston grip to indicate a position of the piston grip.

10. A linear displacement reciprocating pump comprising:

a pump chamber operatively coupled with a piston;

a stop device coupled to the pump chamber or the piston, wherein the stop device comprises a stop body, a stop arm, and a stop engagement member, wherein the stop engagement member is operable to move between a first captured position and a second captured position disposed along the stop body or the stop arm; and

a piston grip coupled to the piston, the piston grip including a grip member that engages an exterior of the piston, wherein movement of the piston grip causes the piston to move axially relative to the pump chamber to control receipt of liquid medicament from a container and delivery of the liquid medicament from the pump chamber.

11. The linear displacement reciprocating pump of claim 10 further comprising a set of side springs coupled to the piston catch, wherein the set of side springs provide a spring force to bias the piston catch toward the pump chamber.

12. A linear volume reciprocating pump according to claim 10, wherein the stop engaging member is a spring.

13. The linear displacement reciprocating pump of claim 10 wherein the stop body extends from a pump housing, wherein the stop arm is directly coupled to an outer surface of the pump chamber, and wherein the stop engagement member extends through an opening of the stop arm.

14. The linear displacement reciprocating pump of claim 10 further comprising a contact signal pin embedded within the stopper body, wherein in the first position the stopper engagement member is in direct physical contact with the contact signal pin, and wherein in the second position the stopper engagement member is not in direct physical contact with the contact signal pin.

15. The linear displacement reciprocating pump of claim 10, further comprising an insulating coating extending along a portion of the stop arm, wherein in a first position the stop engagement member is not in direct physical contact with the insulating coating, and wherein in a second position the stop engagement member is in direct physical contact with the insulating coating.

16. A linear volume reciprocating pump according to claim 10, further comprising a contact member extending from the stop body or the piston grip, wherein the contact member is operable to establish or break contact with one or more contact members.

17. A linear displacement reciprocating pump comprising:

a pump chamber operatively coupled with a piston;

a stop device coupled to the pump chamber or the piston, wherein the stop device comprises a stop body, a stop arm, and a stop engagement member, wherein the stop engagement member is operable to move between a first captured position and a second captured position disposed along the stop body or the stop arm;

a piston grip coupled to the piston, the piston grip comprising a grip member that engages an exterior of the piston, wherein movement of the piston grip causes the piston to move axially relative to the pump chamber to control receipt of liquid medicament from the container and delivery of the liquid medicament from the pump chamber; and

a contact extending from the stop apparatus or the piston grip, the contact operable to establish or break contact with one or more contact members coupled to a pump housing.

18. The linear displacement reciprocating pump of claim 17 wherein the stop body extends from a pump housing, wherein the stop arm is directly coupled to an outer surface of the pump chamber, and wherein the stop engagement member extends through an opening of the stop arm.

19. The linear displacement reciprocating pump of claim 18 further comprising contact signal prongs embedded within the stopper body, wherein in a first position the stopper engagement member is in contact with the contact signal prongs, and wherein in a second position the stopper engagement member is not in contact with the contact signal prongs.

20. The linear volume reciprocating pump of claim 17, wherein the contact comprises a perimeter of the stop body, the stop engagement member, or an L-shaped contact component extending from a perimeter of the stop body, and wherein the one or more contact members comprise a spring extending from a pump housing, an embedded contact signal pin, or a pin coupled to the piston catch.